Randomized phase II trial of UFT plus Cisplatin versus Pemetrexed plus Cisplatin combined with Concurrent Thoracic Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer. North Japan Lung Cancer Study Group Trial 1001 (NJLCG1001)

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2010
INTERVENTION: Patients receive UFT (400mg/m2 per os) on day 1‐14 and cisplatin (80mg/m2 div) on day8 every 3 weeks up to 3 cycles combined with concurrent thoracic radiotherapy (66Gy/33Fr) Patients receive pemetrexed (500mg/m2 div) on day 1 and cisplatin (80mg/m2 div) on day1 every 3 weeks up to 3 cycles combined with concurrent thoracic radiotherapy (66Gy/33Fr) CONDITION: non‐small‐cell lung cancer PRIMARY OUTCOME: Two‐years survival rate SECONDARY OUTCOME: response rate, progression free survival, overall survival, adverse events INCLUSION CRITERIA: 1) Non‐squamous non‐small‐cell lung cancer 2) Chemotherapy‐naive 3) Radiotherapy‐naive 4) Unresectable locally advanced clinical stage IIIA or IIIB 5) ECOG‐PS 0 or 1 6) Measurable lesion by RECIST ver.1.1 criteria 7) Adequate organ function 8) Life expectancy more than 3 months 9) Written informed consent
Epistemonikos ID: d3d92e657bbbd66a28f77bbf9e283b5a1b387e1a
First added on: Aug 22, 2024